Integra® Total Foot System 2832105

GUDID 10381780119210

The Integra Total Foot System open wedge plate is used for fixation for a variety of proximal metatarsal osteotomies. The stem is deepened and tapered for distraction of osteotomy during insertion and solid contact against cortical bone. It contains distal screw holes that are narrowed for an anatomic fit along the distal metatarsal and stems moved proximally on plate to minimize potential interference with proximal joint

Ascension Orthopedics, Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780119210
• NIH Device Record Key: de21536a-ede2-4cc5-a519-f856961cd53c
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® Total Foot System
• Version Model Number: 2832105
• Catalog Number: 2832105
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780119210 [Primary]
HIBCC	M26828321051 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100502

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

[10381780119210]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® Total Foot System]

• M26928021101: The Integra Total Foot System interpositioning plate is used to space apart two bones or a joint
• M26928130041: The Integra Total Foot System One Third Tubular Plate is a 4 -Hole straight utility plate used
• M26928120051: The Integra Total Foot System Fibular Plate is a 5-hole straight utility plate used for fixation
• M26928120041: The Integra Total Foot System Fibular Plate is a 4-hole straight utility plate used for fixation
• M26928321531: The Integra Total Foot System open wedge plate is used for fixation for a variety of proximal me
• M26928321521: The Integra Total Foot System open wedge plate is used for fixation for a variety of proximal me
• M26928330351: Washer used in conjunction with screws for Integra® Total Foot System
• M26928074031: The Integra Total Foot System Tarsalis Plate is a 4-hole diamond-shaped utility plate used for f
• 10381780119746: The Integra Total Foot System Tarsalis Plate is a 4-hole crescentic utility plate used for fixa
• M26928072021: The Integra Total Foot System Tarsalis Plate is a 4-hole crescentic utility plate used for fixa
• M26928082081: The Integra Total Foot System Tarsalis Plate is a 8-hole T-shaped utility plate used for fixatio
• M26928082061: The Integra Total Foot System Tarsalis Plate is a 6-hole T-shaped utility plate used for fixatio
• M26928082051: The Integra Total Foot System Tarsalis Plate is a 5-hole T-shaped utility plate used for fixatio
• M26928081061: The Integra Total Foot System Tarsalis Plate is a 6-hole T-shaped utility plate used for fixatio
• M26928081051: The Integra Total Foot System Tarsalis Plate is a 5-hole T-shaped utility plate used for fixatio
• M26928062101: The Integra Total Foot System Dwyer Displacement Plate has an in step design to stabilize medial
• M26928140061: The Integra Total Foot System Flatline Arthrodesis Plate provides optimum stability for a variet
• M26928140041: The Integra Total Foot System Flatline Arthrodesis Plate provides optimum stability for a variet
• M26928030091: The Integra Total Foot System Rearfoot Reconstruction Plate is a 9-hole plate used for reconstru
• M26928030071: The Integra Total Foot System Rearfoot Reconstruction Plate is a 7-hole plate used for reconstru
• M26928021001: The Integra Total Foot System interpositioning plate is used to space apart two bones or a joint
• 10381780119432: The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a
• 10381780119418: The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a
• 10381780119395: The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a
• 10381780119388: The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a
• M26928020221: The Integra Total Foot System Universal Rearfoot Plate is a 4-hole plate designed to stabilize a
• M26928020201: The Integra Total Foot System Universal Rearfoot Plate is a 4-hole plate designed to stabilize a
• M26928020181: The Integra Total Foot System Universal Rearfoot Plate is a 4-hole plate designed to stabilize a
• M26928020141: The Integra Total Foot System Universal Rearfoot Plate is a 4-hole plate designed to stabilize a
• M26928011041: The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ens
• M26928011031: The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ens
• M26928011011: The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ens
• 10381780119166: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119159: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119128: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119111: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119104: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119081: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780119050: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780119012: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780119005: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118992: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118985: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118923: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118909: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118886: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118862: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118848: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780118817: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780118800: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.